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A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780

NCT06592482 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-20

No results posted yet for this study

Summary

This is a Phase I, multi-centre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 in male and female participants (females of non-childbearing potential) with severe renal impairment not on dialysis, end-stage renal disease (ESRD) on intermittent haemodialysis (HD), or moderate renal impairment (optional) compared with male and female participants (females of non-childbearing potential) with normal renal function. Potential participants will be screened to assess their eligibility to enter the study up to 4 weeks prior to administration of study intervention. Eligible participants will be admitted to the study site on Day -1. On Day 1, an "A" single oral dose of AZD0780 will be administered, and participants will be confined to the study site until after assessments are completed on Day 11.

Conditions

  • Renal Impairment

Interventions

DRUG

AZD0780

A single "A" dose of AZD0780 will be administered in the morning on Day 1 under fasted condition. Study intervention will be administered orally with approximately 240 mL of water.

Sponsors & Collaborators

Principal Investigators

  • Kwabena Ayesu, Medicine · Omega Research Orlando

  • Thomas Marbury, Medicine · Orlando Clinical Research Center

  • Juan Carlos Rondon, Medicine · Clinical Pharmacology of Miami, Inc.

  • Trisha Shamp, Medicine · Nucleus Network

  • Joel Neutel, Medicine · Orange County Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-02
Primary Completion
2024-12-01
Completion
2024-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06592482 on ClinicalTrials.gov